Our client is a development-stage biopharmaceutical company bringing innovations to global markets in multiple therapeutic areas. Their lead compound in oncology, is in late stage clinical development for the treatment of hematological malignancies. In the United States, this compound is being developed in combination with immune checkpoint inhibitors in solid tumors. Their lead cardiovascular program, is in Phase 1 in Europe. Two additional compounds are in early evaluation for oncology and cardiovascular diseases.
Reporting to the Senior Vice President of Quality, this newly created management position will be responsible for the management of all Clinical Quality and Technical Compliance activities across GxP Operations activities in Japan.
This role will support all technical and operational Quality aspects of global research and development, clinical development leading up to approval of CTD sections for all regulatory submissions and approvals with adherence to global guidelines, resulting in minimal audit findings for our outsourced contract partners and Regulatory Agencies.
- Technical review and approval of Process and Analytical Protocols/Reports, Manufacturing Process Documentation, clinical trial documentation, post-marketing activities for compliance with GxPs and ICH guidelines
- Proactively monitor compliance of the companies outsourced activities with respect to company procedures as well as MHLW/PMDA/Tokyo metropolitan government and other regulatory expectations and requirements
- Support implementation of all strategic Quality initiatives across all cross-functional areas and global office sites and provide adept supportive leadership
- Ensure that the company operates in a manner which is fully compliant with applicable GxP’s and international standards resulting in minimal audit findings for outsourced contract partners and from Regulatory Agencies
- Oversight of diligent and timely close-out of product investigations, complaints, deviations associated with release of clinical material and commercial material.
- Manage and oversee effective Quality oversight of the companies Vendor Management Program.
- Provide QA oversight and critical evaluation of all outsourced Validation / Qualification activities.
- Review and approve CMC sections of Regulatory filings on behalf of Quality function.
- Identification and resolution of quality and analytical issues associated with technology transfer.
- Oversight and Review of partnerships / relationships with CDMO/CTL/CRO and where appropriate, manage the relationship through Quality Technical Agreements.
- Support CMC/Manufacturing/Clinical and regulatory aspects of projects in collaboration with multidisciplinary teams according to project plans, timelines, and budgets
- Support all Quality and compliance relations with PMDA, MHLW, and other related health authority agencies
- Support the rollout and implementation of the global training programs
- Identify gaps and improvement opportunities within the quality system and communicate changing quality and clinical compliance requirements with senior management throughout the company
- Comprehensive knowledge of current Japan and ex. Japan regulatory guidelines
- Excellent knowledge of Regulatory Compliance, process and analytical validation and technical transfer. Has a thorough understanding of Japan and international regulatory requirements as they pertain to general Quality.
- Has a thorough understanding of the regulatory process from IND through commercialization.
- Strong project management skills.
- Broad industry experience and technical background encompassing Production, Quality Assurance, Clinical Development, Quality Control and post-marketing activities
- Established track record with evidence of excellent project management, problem solving, collaborative, leadership and communication skills.
- Preference for Strong written and oral communication skills in both Japanese and English
- Able to grasp complex technical issues and make sound decisions based on data and information from various sources
- Ability to foster and promote internal collaboration.
- Educated to degree/masters level in relevant technical/engineering/scientific discipline, preferably multi- disciplinary with a strong technical/scientific orientation.
- An advanced degree desirable. Very good knowledge of Quality Operations (Clinical and Commercial), Quality regulations in Japan.
- Minimum 10-15 years’ experience gained in a pharma manufacturing environment role, minimum of 5-10 yrs at Senior Manager level.
- Experience with regulatory interactions preferably with MHLW, PMDA and Tokyo metropolitan government
- Preferably prior experience with both small molecule and biologics drug development
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